Effect of Jianpi Huatan Decoction on Advanced Colorectal Cancer

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Status and phase: Enrolling; Phase 3

Conditions: Colorectal Neoplasms

Treatments: Drug: Placebo granule; Drug: Jianpi Huatan dispensing granule

Study type: Interventional

Funder types: Other

Identifiers

NCT05187481

CI2021A01803

Details and patient eligibility

About

This study will take progression-free survival and overall survival as the main evaluation indexes, to evaluate the Efficacy of Jianpi Huatan Decoction in the Treatment of Advanced Colorectal Cancer. Decision Trees and Discriminant Analysis will be used to analyze the characteristics of dominant population combined with clinical data of patients. DNA methylation of the subjects will be detected to study the methylation characteristics of the preponderant population of Jianpi Huatan Decoction.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with colorectal cancer with clear pathological diagnosis and Western medicine diagnostic criteria.
2. TNM classification of stage IV disease according to National Comprehensive Cancer Network (NCCN) Guidelines.
3. Expected survival time is over 3 months.
4. The age of 18 years old or more.
5. According to the efficacy evaluation criteria for solid tumors (RECIST 1.1), there are measurable lesions.
6. Chemotherapy and/or targeted therapy are planned.
7. Signed informed consent.

Exclusion criteria

1. History of previous or combined malignancies except non-melanoma skin cancer, cervical cancer in situ, or bladder cancer (Tis and T1) received adequate treatment in the five years prior to screening.
2. Combined with severe heart, liver, lung and kidney disease.
3. Patients have intestinal obstruction can't take decoction and need intravenous high-energy nutrition. Patients have malabsorption syndrome or other disease affecting gastrointestinal absorption or have active peptic ulcer disease.
4. Any unstable condition or condition that may endanger patient safety and compliance with research, such as pregnancy, depression, manic-depressive disorder, obsessive-compulsive disorder, or schizophrenia.
5. The expected survival time is less than 3 months.
6. The researchers determine that they were not suitable for the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

The experimental group will take Jianpi Huatan dispensing granule while receiving chemotherapy and/or targeted therapy, once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.

Treatment:

Drug: Jianpi Huatan dispensing granule

Control Group

Placebo Comparator group

Description:

The experimental group will take Placebo granule (containing 1/10 of the formula dose of Jianpi Huatan Granule) while receiving chemotherapy and/or targeted therapy, once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.

Treatment:

Drug: Placebo granule